US20240122533A1 - Evaluation device, evaluation system, evaluation method, evaluation program, and recording medium - Google Patents

Evaluation device, evaluation system, evaluation method, evaluation program, and recording medium Download PDF

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Publication number
US20240122533A1
US20240122533A1 US18/546,448 US202118546448A US2024122533A1 US 20240122533 A1 US20240122533 A1 US 20240122533A1 US 202118546448 A US202118546448 A US 202118546448A US 2024122533 A1 US2024122533 A1 US 2024122533A1
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United States
Prior art keywords
evaluation
respiratory
severity
target patient
pneumonia
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US18/546,448
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English (en)
Inventor
Shigeru Miyagawa
Yoshiki Sawa
Hidetsugu Asanoi
Sunao IKEGAWA
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Osaka University NUC
Heartlab Inc USA
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Osaka University NUC
Heartlab Inc USA
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Assigned to OSAKA UNIVERSITY, HEARTLAB, INC. reassignment OSAKA UNIVERSITY ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MIYAGAWA, SHIGERU, SAWA, YOSHIKI, IKEGAWA, Sunao, ASANOI, HIDETSUGU
Publication of US20240122533A1 publication Critical patent/US20240122533A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/113—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb occurring during breathing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4842—Monitoring progression or stage of a disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/0816—Measuring devices for examining respiratory frequency
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6887—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient mounted on external non-worn devices, e.g. non-medical devices
    • A61B5/6892—Mats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B2010/0083—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements for taking gas samples
    • A61B2010/0087—Breath samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors

Definitions

  • the present invention relates to a technique for evaluating the severity of pneumonia, and particularly to a technique for evaluating the severity of pneumonia caused by COVID-19.
  • COVID-19 has propagated throughout the world, with the cumulative number of patients exceeding 100 million and the number of deaths reaching 2.1 million in late January 2021. In Japan as well, there were 7,882 new patients in one day on Jan. 8, 2021, and not all of the patients could be hospitalized in medical institutions. In other words, most COVID-19 patients have to stay at accommodation facilities or at home for recovery, and only patients who have become so severe as to require advanced treatment during convalescence have to be hospitalized.
  • COVID-19 is characterized in that it causes complications such as respiratory failure due to pneumonia, cardiovascular diseases such as arrhythmia and cardiac disorder, and thromboembolism such as pulmonary embolism and acute stroke; and rapidly becomes severe and causes death.
  • COVID-19 patients who have stayed at accommodation facilities or at home for recovery check their subjective symptoms, body temperature, and oxygen saturation, and are triaged due to the necessity of inpatient treatment based on the results.
  • subjective symptoms and body temperature have low specificity for pneumonia, and are thus less likely to be factors for determining triage.
  • oxygen saturation is important information for triage, the action of measuring the oxygen saturation by the patient themselves in a poor physical condition and reporting the data to an administrator of a health center or the like is necessary, which is a burden on the patient.
  • even if these are self-checked there are successively cases in which patients who stay at accommodation facilities or at home for recovery die.
  • the present invention has been made to solve the above problems, and an object of the present invention is to easily evaluate the severity of pneumonia.
  • the present invention includes the following aspects.
  • An evaluation device for evaluating the severity of pneumonia in a target patient comprising:
  • An evaluation system comprising:
  • the detection device comprises a sheet sensor provided below the target patient on a bed, and the sheet sensor detects a generated body pressure signal as the signal.
  • An evaluation method for evaluating the severity of pneumonia in a target patient comprising:
  • An evaluation program for causing a computer to operate as each unit of the evaluation device according to any one of Items 1 to 4.
  • a computer-readable recording medium in which the evaluation program according to Item 8 is recorded.
  • the severity of pneumonia is evaluated based on the value of an index indicating instability of a respiratory cycle or a respiratory frequency such as RST. Since the index can be easily monitored from a remote target patient, the severity of pneumonia can be easily evaluated.
  • FIG. 1 shows a block diagram illustrating a schematic configuration of an evaluation system according to an embodiment of the present invention.
  • FIG. 2 shows a schematic diagram illustrating an installation example of a detection device and a relay terminal.
  • FIG. 3 shows a flowchart illustrating a processing procedure of an evaluation method for evaluating the severity of pneumonia of a target patient using the evaluation system according to the embodiment.
  • FIG. 4 shows a box plot comparing RSTs of patients with “moderate disease II/severe disease” and patients with “mild/moderate disease I” as shown in the “COVID-19 Medical Guide” published by the Ministry of Health, Labour and Welfare.
  • FIG. 5 shows a box plot comparing RSTs of patients with a score of “Medium or High” and patients with a score of “Low or Low-medium” as indicated by the National Early Warning Score (NEWS).
  • NEWS National Early Warning Score
  • FIG. 6 shows a box plot comparing RSTs of patients with and without pneumonia images on CT.
  • FIG. 7 shows an ROC curve for the severity of COVID-19 patients.
  • FIG. 1 is a block diagram illustrating a schematic configuration of an evaluation system 1 according to an embodiment of the present invention.
  • the evaluation system 1 is a system for evaluating the severity of the pneumonia of a target patient, and includes a detection device 2 , a relay terminal 3 , an evaluation device 4 , and a viewing terminal 5 .
  • the target patient is a person who is determined to be positive for COVID-19 and stays at home or an accommodation facility for recovery.
  • the detection device 2 and the relay terminal 3 are provided in a home or accommodation facility where the target patient stays.
  • the evaluation device 4 is provided in the cloud
  • the viewing terminal 5 is provided in an institution (health center, hospital, etc.) that performs health monitoring of a target patient.
  • the evaluation device 4 and the viewing terminal 5 may be configured as a single device.
  • FIG. 2 is a schematic diagram illustrating an installation example of the detection device 2 and the relay terminal 3 .
  • the detection device 2 is a device that detects a signal including a respiratory waveform of a target patient, and includes a sheet sensor 21 and a measurement unit 22 .
  • the sheet sensor 21 is a piezoelectric body motion sensor formed of a thin and soft band-shaped piezoelectric rubber, and is provided, for example, on a bed used by a target patient. In FIG. 2 , the sheets and the duvet laid on the sheet sensor 21 are not illustrated. While the target patient is in the bed, pressure is applied to the sheet sensor 21 , and the sheet sensor 21 generates an analog body pressure signal by the piezoelectric effect.
  • the body pressure signal includes, in addition to the respiratory waveform, a waveform due to noise and body motion other than respiration.
  • the measurement unit 22 is connected to the sheet sensor 21 , and the seat sensor 21 performs AD conversion of a generated body pressure signal.
  • the measurement unit 22 has a function of communicating using the relay terminal 3 and Bluetooth (registered trademark), and transmits a body pressure signal to the relay terminal 3 .
  • the relay terminal 3 is composed of a smartphone, and transmits the body pressure signal received from the measurement unit 22 to the evaluation device 4 in the cloud via the internet N. If the measurement unit 22 can be connected to the internet N, the relay terminal 3 may be omitted, and the body pressure signal may be directly transmitted from the measurement unit 22 to the evaluation device 4 .
  • the evaluation device 4 shown in FIG. 1 can be configured as a server device.
  • the evaluation device 4 includes a memory unit 41 , an acquisition unit 42 , a calculation unit 43 , and an evaluation unit 44 .
  • the memory unit 41 can be formed of, for example, an HDD or an SSD.
  • the memory unit 41 stores various data such as an evaluation program D 1 .
  • Each unit of the acquisition unit 42 , the calculation unit 43 , and the evaluation unit 44 may be realized in a hardware manner using a logic circuit or the like, or may be realized in a software manner using a CPU or the like.
  • the respective units can be realized by a CPU or the like of the evaluation device 4 reading the evaluation program D 1 into a main storage device and executing the evaluation program D 1 .
  • the evaluation program D 1 may be downloaded to the evaluation device 4 via a communication network such as the internet N, or may be installed in the evaluation device 4 via a computer-readable non-transitory recording medium such as a CD-R in which the evaluation program D 1 is recorded.
  • the acquisition unit 42 has a function of acquiring a respiratory waveform of a target patient.
  • the acquisition unit 42 extracts a respiratory waveform by removing a waveform due to body motion other than respiration and noise from a body pressure signal received from the detection device 2 via the relay terminal 3 .
  • the calculation unit 43 has a function of calculating the value of the index indicating the instability of the respiratory cycle or the respiratory frequency from the respiratory waveform obtained by the acquisition unit 42 .
  • the calculation unit 43 performs frequency analysis (maximum entropy method) on the respiratory waveform to calculate the respiratory stability time (RST), which is the reciprocal of the standard deviation of the respiratory frequency, as the value of the index.
  • RST is calculated as a reciprocal of a standard deviation of a frequency of 5% or more of a maximum value of a respiratory frequency component, which is obtained by extracting a band of a respiratory cycle from a respiratory waveform.
  • A Standard deviation of frequency of 5% or more of a maximum value of a respiratory frequency component
  • the evaluation unit 44 has a function of evaluating the severity of pneumonia of the target patient based on the value calculated by the calculation unit 43 . In this embodiment, the evaluation unit 44 evaluates that the severity is high when the RST is less than a threshold value.
  • the threshold value is preferably 20 to 30 seconds, and more preferably 26 seconds.
  • the evaluation result by the evaluation unit 44 is stored in the storage unit 41 and is transmitted to the viewing terminal 5 via the internet N.
  • the viewing terminal 5 the RSTs of the target patients are displayed in a list, and the numerical values of the target patients evaluated as having high severity are displayed in a mode (different colors, highlighting, etc.) different from that of the other patients. Accordingly, the user (such as the administrator of the health center) of the viewing terminal 5 can easily identify a target patient who needs to be hospitalized.
  • FIG. 3 is a flowchart illustrating a procedure of an evaluation method for evaluating the severity of pneumonia of a target patient using the evaluation system 1 according to this embodiment.
  • step S 1 the sheet sensor 21 of the detection device 2 detects the body pressure signal of the target patient in the bed.
  • step S 2 acquisition step
  • the acquisition unit 42 of the evaluation device 4 acquires the respiratory waveform of the target patient from the body pressure signal received from the detection device 2 .
  • step S 3 calculation step
  • the calculation unit 43 of the evaluation device 4 calculates the RST from the respiratory waveform acquired by the acquisition unit 42 .
  • step S 4 evaluation step
  • the evaluation unit 44 of the evaluation device 4 evaluates the severity of pneumonia of the target patient based on the value calculated by the calculation unit 43 .
  • step S 5 the viewing terminal 5 displays the evaluation result by the evaluation unit 44 .
  • the severity of pneumonia is evaluated based on the RST.
  • the RST is obtained by automatically extracting and analyzing a respiratory waveform from a body pressure signal generated by the sheet sensor 21 provided under the target patient who is in the bed.
  • the RST is obtained in a non-invasive, unrestrained environment for the patient without requiring special action of the patient themselves, as in the case of a pulse oximeter.
  • the administrator or the like since it is not necessary for the administrator or the like to face the target patient, it is possible to monitor the RST from a remote location easily, inexpensively, and continuously every day even for a patient isolated at home or at an accommodation facility due to an infectious disease such as COVID-19.
  • the RST is less than a certain threshold value, it can be determined that the condition has deteriorated, such as in the onset of pneumonia.
  • the evaluation system when used, it is possible to detect a patient who needs hospitalization treatment based on the RST. As a result, a patient who needs to be hospitalized can be admitted to the hospital in a timely manner; accordingly, it is not only possible to reduce the number of deaths of patients who stay at accommodation facilities or at home for recovery, but to also give the patients a sense of security that they are being monitored remotely.
  • the RST is an index created by the inventors of the present application to quantitatively evaluate a change in breathing pattern.
  • the evaluation system according to this embodiment enables preemptive medical treatment that places importance on individuality, leading to an improvement in the QOL of a patient, such as the avoidance of early treatment and hospitalization, and a medical economic effect.
  • the respiratory waveform is acquired by removing the waveform due to the body motion other than the respiration or the noise from the body pressure signal detected by the sheet sensor.
  • the present invention is not limited thereto; for example, the respiratory waveform may be acquired by a respiratory airflow sensor attached to the skin surface near the nasal cavity of the target patient.
  • a depth sensor, a radar Doppler, an ultrasonic Doppler, or the like may be used as the detection device of the respiratory signal.
  • the above embodiment is preferable from the viewpoint of convenience.
  • the RST is used as an index for evaluating the severity of pneumonia.
  • the RST is not particularly limited as long as it is an index indicating instability of a respiratory cycle or a respiratory frequency equivalent to the RST.
  • the severity of pneumonia may be evaluated in consideration of the respiratory rate and the heart rate in addition to the RST.
  • the calculation unit 43 shown in FIG. 1 calculates the RST, the respiratory rate, and the heart rate from the respiratory waveform, and the evaluation unit 44 evaluates the severity of pneumonia based on the RST, the respiratory rate, and the heart rate. Accordingly, the accuracy of the evaluation can be further improved.
  • the inventors of the present application remotely monitored the RST overnight from the body pressure signal of the sheet sensor 21 using 40 patients throughout Japan (32 COVID-19 patients and 8 pneumonia patients) from Jul. 31, 2020 to Nov. 19, 2020.
  • the sheet sensor 21 a body motion sensor produced by Sumitomo Riko Co., Ltd. was used.
  • FIG. 7 shows the ROC curve at its optimum cut-off value.
  • the sensitivity was 0.727
  • the specificity was 0.700
  • the area under the curve was 0.7227.
  • the RST threshold which is the criterion for evaluating whether a patient falls into the moderate II or severe category, is around 26 seconds. Accordingly, if the RST falls below 20 to 30 seconds, it can be determined that the pneumonia is severe enough to require hospitalization.
  • the present invention is particularly suitable for, but not limited to, monitoring isolated COVID-19 positive individuals.
  • the present invention can be applied in geriatric healthcare facilities to monitor the RSTs of residents, enabling early detection of aspiration pneumonia and other conditions.

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PCT/JP2021/041823 WO2022176287A1 (ja) 2021-02-18 2021-11-15 評価装置、評価システム、評価方法、評価プログラムおよび記録媒体

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